CLINICAL OPERATIONS
Clinical Operations
Clinical trials are integral part of Drug Development. BioScien CRO offers end-to-end services for Phase II to IV clinical trials on small molecules, large molecules and medical devices with fully ICH GCP compliant operations.
A team of well-trained, experience professionals apply their therapeutic, regulatory and operational expertise to consistently solve the challenges that arise during all clinical projects. Clinical operation team conducts phase II – phase IV clinical trials, with ethics, high quality and confidentiality.
Our competency in project management is comprehensive and consistent processes, which conform to global regulatory requirements, from start-up to completion, performance is monitored regularly and measured against contractual timelines. In addition, project costs are tracked to ensure adherence to agreed budgets.
Project Management
We appoint experienced and qualified project managers who are experienced in various therapeutic areas. Project Managers work closely with the sponsor, project team from project kick-off and start-up through completion of the final study report or contract closure to meet their objective.
Our project managers act as a single point of contact for Sponsors throughout the duration of the study, ensuring quality deliverables within the timelines and budget, Protocol-related queries and safety / clinical concerns are addressed through close collaboration of the project managers and medical monitors, ensuring the integrity of clinical trial. Project teams typically consist of a project director, a project manager, a team leader, site monitors and clinical trial assistant.
The project manager’s responsibility:
- Efficient Project Planning & seamless execution
- Allocation of Project Resources
- Meticulous Site Identification and Assessment.
- Contract Management
- Vendor Management
- Develop Monitoring Strategy
- CRA Training
- Monitoring Trip Report Review and Submission
- Proactive Risk Management
- Quality Assurance
Site Management
Our site management team bridges the gap between sites and sponsor in accelerating patient enrolment and effectively managing the trial from start to finish, thus ensuring smooth transit of the trials to the next phase.
BioScien, have highly qualified and trained clinical research coordinator (CRC) at each study site to assist the investigator and site staff with all day-to-day study activities.
The roles and responsibility of CRC includes:
- Protection of research subjects
- Ensuring accurate of data
- Regulatory submissions
- Site preparation for the clinical trial
- Additional staff training
- Interacting with EC/CRO/Labs/Sponsor/PI
- Maintaining clinical trial documents/records
- IP accountability
- Scheduling patients’ visits and ensuring retention till study completion
- Keeping the investigator informed and compliant
Clinical Trial Monitoring
Our clinical monitors are the backbone of every trial conducted at BioScien. Their priority: High-quality data for your regulatory submission.
Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study to:
- Oversee data collection
- Review source documentation and case report forms
- Ensure regulatory compliance
- Resolve data queries
- Conduct interim analyses as requested by clients
Our CRAs are dedicated and qualified for site monitoring, providing understanding of local languages, regulations, customs and business practices
Our clinical monitoring teams deliver faster, more efficient investigator site support and data oversight
- Specialized therapeutic training.
- On-site monitoring, familiar with local customs and regulatory requirements.
- The right approach to monitoring clinical trials.
Our Medical & Safety Monitoring staff, all Physicians (MDs) averaging 5 years of trial experience oversee the protocol eligibility and ensure compliance to national and international guidelines on safety reporting allowing our project teams to execute projects with superior precision in almost every therapeutic area:
Clinical Trial Supply Management
BioScien capabilities include warehousing and distribution of investigational drugs and clinical supplies. These services are often provided as a part of a full clinical services contract but can also be availed of on a stand-alone basis. BioScien has worked with clients in providing CTS management for their clinical trials, the majority being multi-centric Phase III trials. Our facility has been audited by all our sponsors. This has in turn helped us continuously improve our services to meet changing sponsor and regulatory requirements. We have tied up with a logistics services provider to look after your specific requirements.
Our CTS Management services include Procurement of import license, Customs clearance of import shipment, Receipt of inward bulk shipments, Management of local shipments to sites, IP labelling and Randomization generation, Experience with IVRS, Storage of investigational product and other trial supplies, Inventory management